Status:
UNKNOWN
Chronic Anticoagulation With a Reduced Dose Regimen of Rivaroxaban in End-stage Renal Disease Patients
Lead Sponsor:
University Hospital, Tours
Conditions:
Chronic Hemodialysis Patients
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Atrial fibrillation is the most frequent cardiac rhythm disorder and its prognosis is essentially marked by the risk of embolic events. Its treatment is based on long-term oral anticoagulant therapy a...
Detailed Description
Chronic dialysis patients are a special population because the constraints linked to their disease (3 dialyses per week) make them a captive population that nephrologists know perfectly well. If the i...
Eligibility Criteria
Inclusion
- Adult patient ≥ 18 years of age,
- Chronic hemodialysis patient for at least 3 months,
- Affiliated or beneficiary of a social security plan,
- Having signed a written and informed consent.
Exclusion
- Any indication for long-term oral anticoagulation (atrial fibrillation, venous thromboembolic disease, mechanical valve prostheses, intracardiac thrombosis, etc.)
- Double anti-platelet aggregation for any reason or an aspirin dose greater than 160 mg/day
- Uncontrolled hypertension (BP \> 180/110 mmHg)
- Ischemic stroke within 30 days prior to inclusion
- History of major unprovoked hemorrhage (leading to hospitalization or transfusion) regardless of age
- Surgery within 30 days prior to inclusion
- High-risk bleeding condition in addition to renal failure (such as known coagulation disorder, thrombocytopenia (\< 100G/L), active neoplasia of the digestive or urinary tract, or presence of intracranial vascular malformation)
- Severe hepatic impairment
- Use of strong CYP3A4 inducers, including rifampin, St. John's Wort, carbamazepine, phenytoin, phenobarbital
- Non-compliant patients
- Pregnant or breastfeeding women, women of childbearing age without effective contraception
- Contraindication to the administration of an anticoagulant treatment such as anti-phospholipid antibody syndrome
- Known allergy to rivaroxaban or to one of its excipients (lactose monohydrate)
- Patients under guardianship or conservatorship
- Patients already participating in an ongoing study or who have participated in a study that ended less than 30 days prior to the inclusion date.
Key Trial Info
Start Date :
December 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2024
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05410275
Start Date
December 1 2022
End Date
January 1 2024
Last Update
June 8 2022
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